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| Product NDC Code | 23710-100 | ||||
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| Drug Name | Ecoza |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 1442585, 1442590 |
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| Application Number | NDA205175 | ||||
| Labeler Name | Exeltis USA Dermatology, LLC | ||||
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS During clinical trials with Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Quinnova Pharmaceuticals at 1-877-660-6263 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials, 495 subjects were exposed to Ecoza topical foam or vehicle (246 subjects were exposed to Ecoza topical foam, 1% and 249 were exposed to vehicle). Subjects with interdigital tinea pedis applied foam or vehicle once daily for approximately 28 days. During clinical trials with Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.
ECOZA Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS 7.1 Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulant effect. Most cases reported product application with use under occlusion, genital application, or application to a large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ecoza topical foam is an azole antifungal [ see Clinical Pharmacology (12.4) ] . 12.2 Pharmacodynamics The pharmacodynamics of Ecoza topical foam, 1% have not been established . 12.3 Pharmacokinetics The systemic absorption of Ecoza topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects. In the adult trial, 19 subjects (male and female) with tinea pedis applied Ecoza topical foam, 1% once daily for 29 days. Subjects applied a mean daily amount of 2.4 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application. Results (mean ± SD) showed the time to reach peak plasma concentrations (T max ) was 6.8 ± 5.1 h with maximum concentration (C max ) of 417 ± 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC (0-12) ) was 3440 ± 1920 pg-h/ml. In the pediatric trial, 18 subjects (male and female ages 12 - 17) with interdigital tinea pedis and positive fungal cultures were treated with Ecoza topical foam, 1% once daily for 4 weeks. Subjects applied a mean daily amount of 3.2 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 28 at pre-dose and 7 h and 11 h post-dose. The mean ± SD econazole plasma concentration was 397 ± 289, 534 ± 745 and 575 ± 638 pg/mL at pre-dose and 7 h and 11 h post-dose, respectively. 12.4 Microbiology Mechanism of Action Econazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole. Mammalian cell demethylation is less sensitive to econazole inhibition. Activity in vitro and in clinical infections Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [ see Indications and Usage (1) ]. Trichophyton rubrum Epidermophyton floccosum Trichophyton mentagrophytes
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Ecoza topical foam is an azole antifungal [ see Clinical Pharmacology (12.4) ] .
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics The pharmacodynamics of Ecoza topical foam, 1% have not been established .
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics The systemic absorption of Ecoza topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects. In the adult trial, 19 subjects (male and female) with tinea pedis applied Ecoza topical foam, 1% once daily for 29 days. Subjects applied a mean daily amount of 2.4 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application. Results (mean ± SD) showed the time to reach peak plasma concentrations (T max ) was 6.8 ± 5.1 h with maximum concentration (C max ) of 417 ± 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC (0-12) ) was 3440 ± 1920 pg-h/ml. In the pediatric trial, 18 subjects (male and female ages 12 - 17) with interdigital tinea pedis and positive fungal cultures were treated with Ecoza topical foam, 1% once daily for 4 weeks. Subjects applied a mean daily amount of 3.2 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 28 at pre-dose and 7 h and 11 h post-dose. The mean ± SD econazole plasma concentration was 397 ± 289, 534 ± 745 and 575 ± 638 pg/mL at pre-dose and 7 h and 11 h post-dose, respectively.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. None. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Ecoza (econazole nitrate) topical foam, 1% contains the azole antifungal agent, econazole nitrate in an oil-in-water emulsion base consisting of the following inactive ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant. Each gram of Ecoza topical foam, 1% contains 10 mg of econazole nitrate, USP, in a white to off-white foam. Ecoza topical foam, 1% is alcohol (ethanol)-free and for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl) ethyl]-1H-imidazole mononitrate. Econazole nitrate has the molecular formula C 18 H 15 Cl 3 N 2 O. HNO 3 and a molecular weight of 444.70. Its molecular structure is as follows: Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Ecoza topical foam, 1% is for topical use only. Ecoza topical foam, 1% is not for oral, ophthalmic, or intravaginal use. Ecoza topical foam, 1% should be applied to cover affected areas once daily for 4 weeks. For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply once daily for 4 weeks. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Foam, 1%. Each gram of Ecoza topical foam, 1%, contains 10 mg of econazole nitrate in a white to off-white foam. Foam, 1%. ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Ecoza is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum in patients 12 years of age and older. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.ECOZA econazole nitrate DIMETHICONE GLYCERIN POLYSORBATE 20 POVIDONE K30 PROPYLENE GLYCOL STEARIC ACID TROLAMINE WATER BUTANE ECONAZOLE NITRATE ECONAZOLE white to off-white
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies to determine the carcinogenic potential of Ecoza topical foam have not been performed. Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies to determine the carcinogenic potential of Ecoza topical foam have not been performed. Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation.
Microbiology
Microbiology12.4 Microbiology Mechanism of Action Econazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole. Mammalian cell demethylation is less sensitive to econazole inhibition. Activity in vitro and in clinical infections Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [ see Indications and Usage (1) ]. Trichophyton rubrum Epidermophyton floccosum Trichophyton mentagrophytes
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 70 g Canister Label NDC 23710-100-70 ecoza™ (econazole nitrate) topical foam, 1% For Topical Use Only Not for ophthalmic, oral or intravaginal use. Keep Out of Reach of Children Rx Only Net Wt 70g Exeltis Rethinking healthcare PRINCIPAL DISPLAY PANEL - 70 g Canister Label
PRINCIPAL DISPLAY PANEL - 70 g Canister Carton NDC 23710-100-70 ecoza™ (econazole nitrate) topical foam, 1% For Topical Use Only Not for ophthalmic, oral or intravaginal use. Keep Out of Reach of Children Rx Only Net Wt 70g Exeltis Rethinking healthcare PRINCIPAL DISPLAY PANEL - 70 g Canister Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured in the USA for Exeltis USA Dermatology, LLC Florham Park, NJ 07932 PRODERM TECHNOLOGY ® U.S, Patent 5,993,830 1007501-02 Issued: 07/2016
ECOZA: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) The patient should be instructed as follows: Inform patients that Ecoza (econazole nitrate) topical foam, 1% is for topical use only. Ecoza (econazole nitrate) topical foam, 1% is not intended for oral, intravaginal, or ophthalmic use. Ecoza topical foam, 1% is flammable; avoid heat, flame, and smoking during and immediately following application. If a reaction suggesting sensitivity or chemical irritation develops with the use of Ecoza topical foam, 1%, use of the medication should be discontinued.
Instructions for use
Information about safe handling and use of the drug product.Instructions for Use ECOZA ® (ee-ko-zah) (econazole nitrate) topical foam, 1% Important information: Ecoza topical foam is for use on skin only. Do not use Ecoza topical foam in your eyes or vagina. Parts of Ecoza topical foam Canister. (See Figure A ) Figure A How to apply Ecoza topical foam: Step 1: Before you apply Ecoza topical foam, shake the Ecoza topical foam canister for about 5 seconds. Step 2: Remove the cap and turn the Ecoza topical foam canister upside down over the palm of your hand. Step 3: Press down firmly on the actuator until there is a small amount of foam about the size of a golf ball in the palm of your hand. (See Figures B and C ) Figure B Figure C Step 4: Use your finger-tips to scoop up small amounts of Ecoza topical foam and apply to the affected skin areas on your feet. Gently rub the foam into the skin. (See Figure D ) Figure D Step 5: You should apply Ecoza topical foam to your toes, to the spaces between your toes, and to the surrounding areas 1 time a day for 4 weeks or as prescribed by your doctor. Step 6: Replace the cap. Wash your hands after applying Ecoza topical foam. How should I store Ecoza topical foam? Store Ecoza topical foam at room temperature, between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze Ecoza topical foam. Do not store Ecoza topical foam in direct sunlight. Ecoza topical foam is flammable. Keep the Ecoza topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty. Do not puncture or burn the Ecoza topical foam canister. Keep Ecoza topical foam and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for Exeltis USA Dermatology, LLC Florham Park, NJ 07932 Issued: 07/2016 Figure A Figure B Figure C Figure D
| Before you apply Ecoza topical foam, shake the Ecoza topical foam canister for about 5 seconds. | |
| Remove the cap and turn the Ecoza topical foam canister upside down over the palm of your hand. | |
| Press down firmly on the actuator until there is a small amount of foam about the size of a golf ball in the palm of your hand. |
| Use your finger-tips to scoop up small amounts of Ecoza topical foam and apply to the affected skin areas on your feet. Gently rub the foam into the skin. | |
| You should apply Ecoza topical foam to your toes, to the spaces between your toes, and to the surrounding areas 1 time a day for 4 weeks or as prescribed by your doctor. | |
| Replace the cap. Wash your hands after applying Ecoza topical foam. | |
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Patient Information ECOZA ® (ee-ko-zah) (econazole nitrate) topical foam, 1% Important information: Ecoza topical foam is for use on skin only. Do not use Ecoza topical foam in your eyes or vagina. What is Ecoza topical foam? Ecoza topical foam is a prescription medicine used on the skin (topical) to treat athlete's foot that is between the toes (interdigital tinea pedis) in people 12 years of age and older. What should I tell my doctor before using Ecoza topical foam? Before using Ecoza topical foam, tell your doctor about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if Ecoza topical foam will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Ecoza topical foam passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Ecoza topical foam? See the detailed Instructions for Use for information about how to use Ecoza topical foam. Use Ecoza topical foam exactly as your doctor tells you to use it. Apply Ecoza topical foam to the affected skin areas of your feet 1 time a day for 4 weeks. If Ecoza topical foam gets in or near your eyes, rinse them well with water. Wash your hands after you apply Ecoza topical foam. What should I avoid while using Ecoza topical foam? Ecoza topical foam is flammable. Avoid heat, flame and smoking while applying and right after you apply Ecoza topical foam to your skin. What are the possible side effects of Ecoza topical foam? Ecoza topical foam may cause skin reactions at the treatment site. Tell your doctor if you have any skin reactions on the areas of your skin treated with Ecoza topical foam. These are not all the possible side effects of Ecoza topical foam. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Ecoza topical foam? Store Ecoza topical foam at room temperature, between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze Ecoza topical foam. Do not store Ecoza topical foam in direct sunlight. Ecoza topical foam is flammable. Keep the Ecoza topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty. Do not puncture or burn the Ecoza topical foam canister. Keep Ecoza topical foam and all medicines out of the reach of children. General information about the safe and effective use of Ecoza topical foam Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about Ecoza topical foam that is written for health professionals. Do not use Ecoza topical foam for a condition for which it was not prescribed. Do not give Ecoza topical foam to other people, even if they have the same symptoms that you have. It may harm them. What are the ingredients in Ecoza topical foam? Active ingredient: econazole nitrate USP Inactive Ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant. Manufactured for Exeltis USA Dermatology, LLC Florham Park, NJ 07932 For more information call Exeltis USA, Inc. at 1-877-324-9349. This Patient Information has been approved by the U.S. Food and Drug Administration. Issued:07/2016 1007501-02
| Patient Information ECOZA ® (ee-ko-zah) (econazole nitrate) topical foam, 1% | ||
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| This Patient Information has been approved by the U.S. Food and Drug Administration. | Issued:07/2016 | 1007501-02 |
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES In two multi-center, randomized, double-blind, vehicle-controlled clinical trials a total of 505 subjects with interdigital tinea pedis were randomized 1:1 to Ecoza topical foam or vehicle; subjects applied the assigned medication once daily for 4 weeks. The severity of erythema, scaling, fissuring, maceration, vesiculation, and pruritus were graded using a 4-point scale (none, mild, moderate, severe). Subjects had KOH examination and fungal cultures taken to confirm eligibility. A total of 339 subjects with positive fungal cultures were evaluated for efficacy. Efficacy was evaluated on Day 43, 2 weeks post-treatment with treatment success being defined as complete cure (negative KOH and fungal culture and no evidence of clinical disease). The study population ranged in age from 12 to 71 years with 5 subjects less than 18 years of age at baseline. The subjects were 71% male and 51% Caucasian. Table 1 presents the efficacy results for each trial. Table 1: Efficacy Results at Two Weeks Post-treatment (Day 43) Complete Cure, Effective Treatment and Mycological Cure Trial 1 Trial 2 Ecoza topical foam, 1% N = 82 n(%) Foam Vehicle N = 83 n(%) Ecoza topical foam, 1% N = 91 n(%) Foam Vehicle N = 83 n(%) Complete cure Mycological cure and an absence of clinical signs and symptoms (erythema, scaling, fissuring, maceration, vesiculation, or pruritus). 19 (23.2%) 2 (2.4%) 23 (25.3%) 4 (4.8%) Effective treatment Mycological cure and no or mild erythema and/or scaling with all other signs and symptoms absent. 40 (48.8%) 9 (10.8%) 44 (48.4%) 9 (10.8%) Mycological cure Negative KOH and fungal culture. 56 (68.3%) 13 (15.7%) 61 (67.0%) 15 (18.1%)
| Trial 1 | Trial 2 | |||
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| Ecoza topical foam, 1% N = 82 n(%) | Foam Vehicle N = 83 n(%) | Ecoza topical foam, 1% N = 91 n(%) | Foam Vehicle N = 83 n(%) | |
| 19 (23.2%) | 2 (2.4%) | 23 (25.3%) | 4 (4.8%) | |
| 40 (48.8%) | 9 (10.8%) | 44 (48.4%) | 9 (10.8%) | |
| 56 (68.3%) | 13 (15.7%) | 61 (67.0%) | 15 (18.1%) | |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Of the 173 subjects treated with Ecoza topical foam, 1% in the adult clinical trials, 6 subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.8.3 Nursing Mothers It is not known whether econazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Of the 173 subjects treated with Ecoza topical foam, 1% in the clinical trials, 2 subjects were 12 to 17 years old. In a pediatric maximal use trial, Ecoza topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [ see Clinical Pharmacology (12.3) ]. The safety findings for subjects 12 to 17 years were similar to those in adult population.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled trials with Ecoza topical foam in pregnant women. Ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Pregnancy Category C There are no adequate and well-controlled trials with Ecoza topical foam in pregnant women. Ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled trials with Ecoza topical foam in pregnant women. Ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. 8.3 Nursing Mothers It is not known whether econazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. 8.4 Pediatric Use Of the 173 subjects treated with Ecoza topical foam, 1% in the clinical trials, 2 subjects were 12 to 17 years old. In a pediatric maximal use trial, Ecoza topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [ see Clinical Pharmacology (12.3) ]. The safety findings for subjects 12 to 17 years were similar to those in adult population. 8.5 Geriatric Use Of the 173 subjects treated with Ecoza topical foam, 1% in the adult clinical trials, 6 subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/ STORAGE AND HANDLING Ecoza topical foam, 1% is white to off-white foam supplied in 10g (NDC 23710-100-10) and 70g (NDC 23710-100-75) aluminum pressurized canister. Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Ecoza topical foam is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.
Storage and handling
Information about safe storage and handling of the drug product.Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Ecoza topical foam is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API